ISO 9001 QMS Course

ISO 9001:2015 Standard
QUALITY MANAGEMENT SYSTEM

Course Objective
When you completed the course you will be able to:
• Understand the concept of QMS standard
• Describe the QMS standards
• Apply QMS standard in the organization

Course Outline
This is a One (1) day course containing the following:
•History of International Organization for Standardization (ISO)
•ISO 9000 Series of Standards
•Changes in ISO 9001:2008 to 9001:2015
•ISO 9001 Quality Management Requirements
•Internal Audit Course

History
Understanding Quality Management?
• Quality refers to all those features of a product (or service) which are required by
the customer.
• Quality Management means what the organization does to

ensure that its products or services satisfy the customer's quality requirements and
comply with any regulations applicable to those products or services.
ISO 9000 Family Series of Standard
ISO 9000:2015 ISO 9001:2015 ISO 9004:2018

Quality Management Quality Management Managing for the sustained
Systems - Systems - Requirements success of an organization
Fundamentals and —
Vocabulary A quality management
approach
Requirements aimed primarily
Essential background at giving confidence in the Guidance for organizations
for products and services that choose to progress
the proper an organization provides,
beyond ISO 9001
understanding and thereby improving
customer satisfaction
requirements to address
implementation of
a broader range of topics
ISO 9001
that can lead to continual
improvement of the
organization's overall
ISO 9000:2015 Quality Management Fundamentals and Vocabulary
Has seven quality management principle:
1.Customer Focus
2.Leadership
3.Engagement of people
4.Process approach
5.Improvement
6.Evidence-based decision making
7.Relationship management
Workshop I
Based on the seven Quality Management Principles:
1. Define the seven principles

2. Choose one (1) principle and give an example on how can you apply this principle
in the organization
ISO 9001:2015 Quality Management System
– Requirements
RISK-BASED THINKING
RISK-BASED THINKING
RISK-BASED THINKING
Workshop II
Consider a new product or services in the organization and Identify the following:
1.At least two (2) Requirements
2.Two (2) Risk
3.Two (2) Opportunities.
Other ISO Standards
SAE
ISO TS ISO QUEST
AS9100C:2009
16949:2009 13485:2003 TL9000
Aerospace Automotive Med. devices Telecom
ISO 9001
ISO 9000
ISO 9001:2008 vs 9001:2015
Key Changes
• increased emphasis on Achieving Value for the organisation and its customers
• increased emphasis on understanding and control of Risk to the organisation
• reduced emphasis on Documentation
• no stated requirement for Documented Procedures
• no reference to a Quality Manual.

And………
• no requirement for a Management Representative
• no formal requirement for Preventive Action
• outsourcing is now External Provision
• enhanced Leadership Requirements
• Organisational Context – responsiveness to changing Business Environment
• No exclusions, only Not Applicable clauses!

ISO 9001:2015
Quality Management Systems –
Requirements.
Section 4 – Context of the Organisation
Section 4 – Context of the Organisation
4.1 Understanding the • this is a new clause and
organisation and its context
provides a key insight
4.2 Understanding the needs into the organisation
and expectations of
interested parties What constitutes the
4.3 Determining the scope of organisation’s quality
the quality management management system.
system
4.4 Quality management
system and its processes
Section 4 – Context of the organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
•determine external and internal issues relevant to the QMS

•must monitor these issues.
4.2 Understanding the needs and expectations of interested parties
•determine interested parties relevant to the QMS

•determine their needs and expectations
•must monitor information about interested parties’ requirements.
4.2 Understanding the needs and expectations of interested
parties
4.3 Determining the scope of the quality management
system
•establish scope by determining boundaries and applicability of the

QMS to consider external/internal issues, requirements of interested
parties and the organisation’s products and services
4.2 Understanding the needs and expectations of interested
parties
•must establish, implement, maintain and continually improve

the QMS
•interaction of processes required (but not documented!)
•assign responsibilities and authorities for processes
•retain documented information to ensure in the processes
Section 5 - Leadership
Section 5 – Leadership
5.1 Leadership and • top management now have
commitment a greater involvement in the
QMS
5.2 Policy
5.3 Organisational roles, What is required by top
responsibilities and management.
authorities
5.1 Leadership and commitment
5.1.1 General
5.5.1 Customer focus
5.2 Policy
5.3 Organisational roles, responsibilities and authorises
•new clause
•must take accountability for the QMS’ effectiveness
•ensure Quality Policy and quality objectives are established
•ensure QMS is integrated into business processes
•ensure resources are available;
5.1.1 General…cont
5.2 Policy
•communicate importance of effective QMS and conformance

•ensure QMS achieves intended results
•promote improvement
•support other management to demonstrate leadership.
5.1.1 General
5.2 Policy
•top management must ensure:
•customer and regulatory requirements are met
•risks and opportunities are determined and addressed
•focused on enhancing customer satisfaction.

5.2 Policy
5.3 Organisational roles, responsibilities and authorities
•now split into two sub-clauses to save the confusion in the previous
version of what must be in the policy and what must be done with the
policy
•must be documented
•must be available internally and to interested parties.

5.2 Policy
5.3 Organisational roles, responsibilities and authorities
•ensures responsibilities and authorities for relevant roles are assigned,

communicated and understood
•no formal requirement for specific management representative
•specific mention of changes to QMS.

Section 6 – Planning
6.1 Actions to address risks • introduces risk based
and opportunities approach to planning
6.2 Quality objectives and • addresses risks,
planning to achieve opportunities and quality
them objectives
6.3 Planning of changes How quality planning is

achieved.
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
•when planning, must consider external/internal issues and interested

parties
•determine risks to ensure QMS achieves results, enhance desirable

effect and achieve improvement
•must evaluate effectiveness of actions
•must be risk based.

•quality objectives need to be established at relevant functions, levels and
processes
•these objectives should be:
─ consistent with the Quality Policy, measurable and take into account
applicable requirements
─ relevant to conformity of products and services, and the enhancement
of customer satisfaction
─ monitored, communicated and updated as appropriate
•must determine what, how, who, when, etc
•quality objectives must be documented.
•where change is needed, it needs to be carried out in a planned and

systemic manner
•must ensure integrity of QMS.

Section 7 - Support
Section 7 - Support
7.1 Resources • newly constructed clause
7.2 Competence
• much of what was in 2008
Version Clauses 4,5 & 6
7.3 Awareness
7.4 Communication
The support required to meet
the organisation’s goals.
7.5 Documented information
Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organisational knowledge
•must provide resources for the implementation and maintenance of

the QMS
•must consider constraints of existing resources and what may be

provided from external providers.
Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
•must determine and provide people necessary for effective

information of QMS and operations/control of processes.
Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
•determine resources needed to ensure valid and reliable monitoring and

measuring results
•resources must be suitable for the activity and maintained as fit for purpose
•evidence of fit for purpose must be retained
•other requirements for measuring equipment unchanged.
Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
•new clause required to determine, maintain and make available the

knowledge necessary for the operation of its processes and to achieve
conformity of products and services
•particular care required for changing need and trends.

7.1.6 Organisational Knowledge
Note:
•organisational knowledge can include information such as intellectual

property and lessons learned
•may consider:
─ internal sources (eg learning from failures and successful projects,

capturing undocumented knowledge and expert experience)
─ external sources (eg standards, training, conferences, knowledge

from customers or providers).
Section 7 - Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
•providing ‘training’ to ‘competence’
•documented information (record) must be obtained of competence.

Section 7 - Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
•must be aware of Quality Policy, quality objectives, contribution to

effective QMS and implication of not conforming with QMS.
Section 7 - Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
•must now determine what will be communicated internally and

externally about the QMS, when, to whom, how and by whom.
Section 7 - Support
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
•QMS needs documented information required by the Standard and

as determined by the organisation
Note: the extent of documented information can differ from one

organisation to another due to its size, activities, processes, products
and services, complexity of processes and their interactions, and the
competence of people.
Section 7 - Support
7.5.1 General
•documented information requires:
▫ identification and description
▫ format and media
▫ review and approval.

Section 7 - Support
7.5.1 General
•combines previous Clauses 4.2.3 (documentation) and 4.2.4

(records).
Section 8 - Operation
8.1 Operational planning and control • covers many of the
8.2 Requirements for products and Product Realisation
services requirements
contained in Clause 7
8.3 Design and development of
of the 2008 version
products and services
8.4 Control of externally provided
The heart of the
processes, products and services
management system
8.5 Production and service provision (the business).
8.6 Release of products and services
8.7 Control of nonconforming outputs
8.1 Operational planning and control
•must plan, implement and control processes needed to meet

requirements for the provision of products and services
•must control planned changes and review unintended changes
•any outsourced processes must be controlled.

8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of requirements for products and services
8.2.4 Changes to requirements for products and services
•includes communicating with customers about handling and controlling

their property, establishing contingency requirements, when relevant.
8.2 Determination of requirements for products and services
•plus the organisation must meet the claims of products or services it

offers.
8.2 Determination of requirements for products and services
•documented information required on results of the review and any

new requirements.
8.3 Design and development of products and services
•where the detailed requirements of the organisation’s products and

services are not already established or not defined by the customer or
by other interested parties, such that they are adequate for
subsequent production or service provision, the organisation shall
establish, implement and maintain a design and development
process;
8.3 Design and development of products and services…cont
•changes are mainly terminology and simplified wording
•there is, however, a significantly increased focus on the role the

customer has in all stages of the design process
•the need for documented information to confirm appropriateness of all

stages is also clearly stated
•any changes made to design inputs and design outputs during the
design and development must be clearly identified.
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
•much as before, each stage of the purchasing process, including

evaluation, selection, performance monitoring and re-evaluation remains a
key requirement
•there is a significant increase in the steps needed to control external

provision.
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
• the most significant change is the move of monitoring and measuring

equipment to Section 7
• reference to ‘changes and post delivery activities’ have been strengthened.
8.5.4 Preservation
8.5.4 Preservation
8.5.4 Preservation
8.5.4 Preservation
8.5.4 Preservation
8.5.4 Preservation
•specific clause for control of changes to ensure continuing conformity
•documented information must be retained describing the review of

changes and any action arising.
8.6 Release of products and services
• must verify that product and service requirements have been meet
and evidence of conformity retained
• release to customer does not proceed until the planned verification

of conformity has been satisfactorily completed, unless otherwise
approved by a relevant authority and by the customer
• documented information to provide traceability to the person(s)

authorising release for delivery to the customer.
8.7 Control of nonconforming outputs
•documented information required describing nonconformity, actions

taken, any concessions and authority for taking action.
Section 9 – Performance Evaluation
9.1 Monitoring, Determining what is to be
measurement, analysis monitored, measured, analysed
and evaluation and evaluated will enable the
organisation to determine ‘if the
9.2 Internal audit management system suitable,
9.3 Management review adequate and effective ?’
How performance of the QMS

is evaluated.
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
•must determine what needs to be monitored and measured, the methods

for monitoring, measurement, analysis and evaluation, as applicable, to
ensure valid results
•additionally, when the monitoring and measuring is to be performed and

when the results from monitoring and measurement is to be analysed and
evaluated
•retain appropriate documented information as evidence of the results.

9.1.1 General
9.1.1 General
•information resulting from monitoring and measuring appropriate data

should be analysed and evaluated
•the results of analysis is to be used to evaluate seven specific criteria

described.
9.2 Internal audit
9.3 Management review
•split into two sub-clauses
•still at planned intervals
•evidence of internal audits and results must be documented.

9.2 Internal audit
9.3 Management review
•still at planned intervals
•clearer agenda items (inputs)
•evidence of management review results must be documented.

Section 10 - Improvement
10.1 General • QMS must continually

improve
10.2 Nonconformity and
• nonconformities must be
corrective action
identified and reacted to
10.3 Continual improvement • corrective action must be
considered
Continual improvement
remains a core focus of
the QMS.
Section 10 – Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
•opportunities for improvement must be determined
•action must be taken to meet customer requirements and enhance

customer satisfaction:
▫ improve products and service
▫ correcting, preventing or reducing undesired effects
▫ improve performance and effectiveness of the QMS.

10.1 General
•nonconformities (including complaints) must be reacted to and applicable

action taken
•root cause analysis must be considered based on its significance
•effectiveness of corrective action must be reviewed
•change QMS if required
•evidence of action taken from nonconformities must be documented
•evidence of results of corrective action must be documented.

Section 10 – Improvement
10.1 General
•organisations must continually improve the suitability, adequacy and

effectiveness of the QMS
•must consider results of analysis and evaluation, and outputs from

management review.
Workshop III
Apply the Plan-Do-Check-Act to ISO clauses
Plan-Do-Check-Act
Plan-Do-Check-Act Concept
.
Workshop IV
Organizational Design Concept as per ISO Clauses:
Clause 4 (Plan)
4.1 Understanding the organization and its context
4.2 Determine the Scope of the QMS
Clause 5 (Plan)
5.2 Quality Policy
5.3 Organizational Roles, Responsibilities, and Authority
Clause 6 (Plan)
6.2 Quality objective and planning to achieve them
Clause 7 (Do)
7.2 Competence
Clause 8 (Do)
8.2 Requirements for product and services
Clause 9 (Check)
9.3 Management Review
Clause 10 (Act or Plan)
10.3 Continual Improvement
Any Questions?

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ISO 9001:2015 Standard

QUALITY MANAGEMENT SYSTEM

• Understand the concept of QMS standard

• Describe the QMS standards

• Apply QMS standard in the organization

•History of International Organization for Standardization (ISO)

•ISO 9000 Series of Standards

•Changes in ISO 9001:2008 to 9001:2015

•ISO 9001 Quality Management Requirements

•Internal Audit Course

• Quality Management means what the organization does to

ISO 9000:2015 ISO 9001:2015 ISO 9004:2018

1. Define the seven principles

Aerospace Automotive Med. devices Telecom

• increased emphasis on understanding and control of Risk to the organisation

• reduced emphasis on Documentation

• no stated requirement for Documented Procedures

• no reference to a Quality Manual.

• no formal requirement for Preventive Action

• outsourcing is now External Provision

• enhanced Leadership Requirements

• Organisational Context – responsiveness to changing Business Environment

• No exclusions, only Not Applicable clauses!

•determine external and internal issues relevant to the QMS

•determine interested parties relevant to the QMS

•establish scope by determining boundaries and applicability of the

•must establish, implement, maintain and continually improve

•communicate importance of effective QMS and conformance

•top management must ensure:

•customer and regulatory requirements are met

•risks and opportunities are determined and addressed

•focused on enhancing customer satisfaction.

•must be available internally and to interested parties.

•ensures responsibilities and authorities for relevant roles are assigned,

•no formal requirement for specific management representative

•specific mention of changes to QMS.

6.3 Planning of changes How quality planning is

•when planning, must consider external/internal issues and interested

•determine risks to ensure QMS achieves results, enhance desirable

•must evaluate effectiveness of actions

•must be risk based.

•where change is needed, it needs to be carried out in a planned and

•must ensure integrity of QMS.

•must provide resources for the implementation and maintenance of

•must consider constraints of existing resources and what may be

•must determine and provide people necessary for effective

•determine resources needed to ensure valid and reliable monitoring and

•new clause required to determine, maintain and make available the

•particular care required for changing need and trends.

•organisational knowledge can include information such as intellectual

─ internal sources (eg learning from failures and successful projects,

─ external sources (eg standards, training, conferences, knowledge

•providing ‘training’ to ‘competence’

•documented information (record) must be obtained of competence.

•must be aware of Quality Policy, quality objectives, contribution to

•must now determine what will be communicated internally and

•QMS needs documented information required by the Standard and

Note: the extent of documented information can differ from one

•documented information requires:

▫ identification and description